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A Study of Rocbrutinib Combined With R-GemOx in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of May 30, 2026 to Jun 25, 2026 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of May 30, 2026 to Jun 25, 2026
    • Site details revised at 2 of 2 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter, open-label phase Ib study, evaluating the safety, tolerability, preliminary efficacy and PK characteristics of Rocbrutinib (LP-168) combined with R-GemOx in patients with R/R non-GCB DLBCL. Study includes dose escalation part and dose expansion part. In the dose escalation part, a classic "3+3" design will be used to assess the safety of each specified dose combination. Upon completion of a predefined escalation part, the decision on whether to proceed to the dose expansion part will be based on the safety, PK, and efficacy data of the combination regimen.
Trial Details
NCT Number NCT07570017
Lead Sponsor Guangzhou Lupeng Pharmaceutical Company LTD.
Conditions DLBCL
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov